Suturing device, system, and method

ABSTRACT

Improved medical suturing devices, systems, and methods may hold a suture needle at a fixed location relative to a handle of the device, allowing the surgeon to grasp and manipulate the handle of the suturing device to insert the needle through tissues in a manner analogous to use of a standard needle gripper. Cycling the handle from a closed position to an open position and back to the closed position may alternate the device between gripping the needle with a first clamp (for example, along a proximal portion of the needle) to gripping the needle with a second clamp (for example, along a distal portion of the needle) and optionally back to gripping with the first clamp, with the needle often staying at a substantially fixed location relative to the suturing device body. Related single-clamp needle grasping devices can be bent plastically by a surgeon, and/or have bodies that are grasped by a hand while a portion of the hand actuates a handle.

CROSS-REFERENCE TO RELATED APPLICATION

This is application is a continuation of U.S. patent application Ser.No. 11/532,032 filed Sep. 14, 2006, which is a continuation-in-partpatent application which claims priority from U.S. patent applicationSer. No. 11/227,981 filed Sep. 14, 2005, the full disclosures of whichare incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to medical devices, systems, andmethods. In specific embodiments, the invention provides devices,systems, and methods for suturing tissues in open surgery, minimallyinvasive surgical procedures, and the like.

Although many aspects of surgery have changed radically over the lastseveral decades, some surgical techniques have remained remarkablyconstant. For example, as was true fifty years ago, suturing remains acommon technique for approximation of tissues, ligation of tissues,affixing tissues together, and the like.

Suture has been used in open surgical procedures for generations totherapeutically treat diseased tissue and to close surgical access sitesand other wounds. More recently, the use of minimally invasive surgicaltechniques has expanded, with surgical therapies often being performedat internal surgical sites. Although a wide variety of visualizationtechniques (including laparoscopes and other endoscopic viewing devices,fluoroscopy and other remote imaging modalities, and the like) have beendeveloped to allow surgeons to view these internal surgical sites, andalthough a large variety of new tissue treatment techniques have beendeveloped (including ultrasound techniques, electrosurgical techniques,cryosurgical techniques, and the like) and are now widely available,many modern surgical interventions continue to rely on suturing.

A wide variety of alternatives to suturing of tissues have beendeveloped, and have gained varying degrees of acceptance in certainsurgical procedures. Staples and tissue adhesives are used quitefrequently in many open and minimally invasive surgical settings, and avariety of tissue welding techniques have also been proposed.Nonetheless, suturing remains ubiquitous in surgery, as suturingprovides a number of advantages over many of the alternatives.

Suture's advantages include the large knowledge and skill base thatsurgeons have developed over the years. Additionally, a variety ofoff-the-shelf, pre-packaged surgical needles with suture are availablefrom a large number of suppliers at very reasonable cost. Surgeons areable to precisely control the location of suture stitches by graspingthe suture needle and first pushing it and then pulling it through thetarget tissue. In open surgery the surgeon may manually grasp the sutureneedle directly with his or her hand, although both open and minimallyinvasive procedures are often performed by grasping the needle with aneedle grasping tool and manipulating the tool to place the suturestitches. The results obtained using suture are highly predictable,although dependent on the skill of the surgeon. In light of itsadvantages, the use of suture does not appear likely to disappear anytime soon, with even modern robotic surgical techniques often making useof suture.

Although suture remains popular in surgery at least in part due to itssignificant advantages, suturing is not without disadvantages. Inparticular, placing a large number of suture stitches can be tiring andquite time-consuming. Manipulation of a suture needle can be difficulteven in open surgery due to the limited space that is often availablearound the target tissues. The challenges of manipulating suture needlesmay be even greater in minimally invasive surgical procedures, where theneedles are often manipulated using long-handled tools extending througha small aperture, typically while viewing the procedure on a displaywhich is offset from the surgical site. Tying knots with a desiredamount of tension and the like may call for intricate and precisemanipulation of the suture, further complicating and delaying open andminimally-invasive surgeries. In fact, the time spent closing/suturingthe access site may be significantly greater than the time spenttreating the underlying target tissues for many procedures.

There have been a variety of proposals for modifications to standardsurgical suturing structures and methods to try to address the abovedisadvantages. At least some of these proposals may seek to rely onspecialized and/or proprietary suturing needle systems, which couldincrease costs and preclude their wide acceptance, especially in thirdworld countries. Unfortunately, many proposals for modifying existingsuturing techniques may also decrease the surgeon's control over theplacement of the suture, such as by relying on an automated or indirectmechanical movement of a device to drive a suture needle into and/orthrough tissues. While these new proposals have in the past or may inthe future gain varying degrees of acceptance in one or more surgicalprocedures, standard suturing techniques continue to predominatethroughout surgery in general.

In light of the above, it would be desirable to provide improvedsuturing devices, systems, and methods. It would be generally desirableto maintain some, most, or all of the advantages of standard suturingtechniques, preferably while decreasing the time required for suturing,the strain on the surgeon, the training involved in achieving competenceor time-efficiency in suturing techniques, or the like. It would beparticularly advantageous if these improvements could be providedwithout requiring extensive capital investments for new equipment,without significant increases in complexity of the suturing process, orwithout having to resort to specialized or proprietary suturing needlesand the like. Alternative needle grasper structures which increased theease and accuracy of stitching, and/or which are readily adapted for avariety of different procedures and patient physiologies would also bedesirable.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides improved medical suturingdevices, systems, and methods. Embodiments of the invention provideimproved suturing devices and methods that maintain some or all of theadvantages of standard open and/or minimally invasive suturingtechniques while providing enhanced speed and ease of use. Exemplarysuturing devices may hold a suture needle at a fixed location relativeto a handle of the device, allowing the surgeon to grasp and manipulatethe handle so as to insert the needle through the tissues to be suturedin a manner closely analogous to use of a standard needle gripper.Cycling of the handle of the device from a closed position to an openposition and back to the closed position may result in the needle beingalternatingly gripped by a first clamp (for example, along a proximalportion of the needle, suitable for insertion of the tip of the needleinto and through tissue), and then by a second clamp (for example, alonga distal portion of the needle, suitable for pulling the protrudingneedle out from the tissue), and optionally again by the first clamp(ready for initiation of the next stitch). The needle will often remainat a substantially fixed location relative to the body and handle of thesuturing device during at least the insertion and/or pulling of theneedle through the tissue, allowing the surgeon to maintain precisecontrol over needle movement and positioning of the suture.Advantageously, standard off-the-shelf suturing needles with theirattached suture may be used, and the device may be employed in an opensurgical setting or a minimally invasive procedure. Needle graspingdevices and methods are also provided which can be bent plastically by asurgeon for use in a particular patient, and/or having advantageousergonomics for use in surgery, these needle graspers optionally havingonly a single clamp for grasping of an associated needle.

In a first aspect, the invention provides a suturing method. Thesuturing method comprises inserting a distal portion of a suturingneedle distally through a tissue by moving a body of a suturing device.The body is moved while a clamp of the suturing device holds the needleat a fixed location relative to the body. The distal portion of theneedle is grasped with a second clamp of the suturing device, and theproximal portion of the needle is released from the first clamp. Theproximal portion of the needle is pulled through the tissue by movingthe body while the second clamp holds the needle.

The second clamp will often hold the needle at a fixed location relativeto the body of the suturing device while the needle is pulled free. Theneedle may also remain at a substantially fixed location relative to thebody of the suturing device while alternating the clamps, for example,by grasping the proximal portion of the needle with the first clamp andonly then releasing the distal portion of the needle from the secondclamp. The inserting of the distal portion of the needle into the tissuewith the first clamp, switching clamps, and then pulling the proximalportion of the needle through the tissue with the second clamps cansignificantly facilitate forming a plurality of suture stitches, and mayavoid completely releasing the needle and/or re-aligning the needle withthe device each time a stitch is formed. Handing the needle back andforth between the first and second clamps will often be effected byactuating a handle of the suturing device with a hand of a surgeon, thehandle typically moving from an open handed configuration to a closedgrasp configuration. Preferably, the handle will be in the closed graspconfiguration at least while inserting the distal portion of the needleinto tissues.

In the exemplary embodiments, cycling the handle (for example, fromclosed to open, and back to closed) alternates which clamp of thesuturing device is supporting the needle from the first clamp, to thesecond clamp, and back (optionally) to the first clamp. By having bothclamps supporting the needle for at least a portion of the handleactuation cycle, unintended movement of the needle relative to the bodyof the device (and the handle) can be inhibited.

The suturing device body will often include a housing containing alinkage, and the linkage may include an alternatable drive element. Thelinkage will often drivingly couple the handle to the first and secondclamps. With each handle actuation cycle, the alternatable drive elementmay move back an forth between a first configuration and a secondconfiguration. In its first configuration, the alternatable driveelement may drive a first portion of the linkage coupled to the firstclamp. In its second configuration the alternatable drive element maydrive a second portion of the linkage coupled to the second clamp.

In an exemplary embodiment, the handle actuation cycle may effectrotation of a drive wheel. The first and second linkage portions mayeach comprise a driven wheel, and the alternatable drive element in thefirst configuration may drivingly couple the drive wheel with the drivenwheel of the first linkage portion. In the second configuration of thealternatable drive element, it may drivingly couple the drive wheel witha driven wheel of the second linkage portion. The alternatable driveelement may be, for example, slidingly or pivotally attached to thedrive wheel and may move back and forth so as to engage surfaces of thedriven wheels on either side of the drive wheel, with the wheels beingdriven about a common axis. Other linkage embodiments may employ analternatable drive element in the form of a slider having alterativepositions during axial movement, or the like. Still further alternativelinkage embodiments may employ rack and pinion gears and cams, cables,and/or the like, with or without alternatable drive elements.

In many embodiments, the first clamp will be displaced laterally fromaround an axis of the needle when the second clamp is used to move theneedle through tissue. Similarly, the second clamp may be displacedlaterally from around the needle when the first clamp is used to movethe needle through tissue. Each clamp may, for example, be mounted to anassociated shaft, and these shafts may reciprocate so as to extenddistally from a housing of the body before closing of the clamp aroundthe needle. In some embodiments, the clamp may also pivot about an axisof the shaft while moving between a retraced position and an extendedneedle grasping position. A spring or other biasing means may inhibitclosing of the clamp before the clamp is properly disposed around theneedle, or the linkage may otherwise be configured to extend the shaftbefore closing of the clamp. In some embodiments, the shafts, clamps,and needle may move axially slightly relative to the housing of the bodywhen the handle is cycled.

Conveniently, a release input may be provided on the suturing device soas to release the needle from both the first and second clamps. Theneedle may comprise an off-the-shelf needle which is sold primarily forstandard open or laparoscopic procedures. These needles often comeprepackaged with suture, and are available in a large variety of needlesizes and configuration, suture types (including resorbable andnon-resorbable sutures), and the like, often at very modest costs.Alternatively, specialized needles may also be employed. An alternatablelatch may optionally maintain either of the clamps closed over theneedle during needle manipulation. The body and handle may be configuredso that a rigid portion of the body can be comfortably grasped by thehand while a portion of the hand (such as the fingers) articulates thehandle, so that inadvertent movement of the body and needle relative tothe hand is inhibited. The surgeon may optionally plastically bend adistal extension of the body along its longitudinal axis for use with aparticular patient physiology. In such embodiments, drive componentswithin the body will typically be sufficiently flexible to allowoperation of the clamps through the bent body

In another aspect, the invention provides a suturing device for use witha suture needle. The device comprises a body having a proximal end and adistal end. A first clamp is disposed near the distal end of the body. Asecond clamp is also disposed near the distal end of the body. A linkageeffects movement of the first and second clamps between a graspingconfiguration and a displaced configuration. Each clamp grasps theneedle at an associated grasping location in the grasping configuration,and is laterally displaced from the needle in the displacedconfiguration. The grasping locations are substantially fixed relativeto the body.

In another aspect, the invention provides a suturing device for use witha suturing needle. The device comprises a body having a proximal end anda distal end. A handle is disposed near the proximal end of the body.The handle is actuatable from a first configuration to a secondconfiguration and back to the first configuration so as to define anactuation cycle. A first clamp and a second clamp are disposed near thedistal end of the body, and the clamps are coupled to the handle so thatan actuation cycle initiated while the first clamp is grasping theneedle results in grasping of the needle with the second clamp andrelease of the needle from the first clamp, and (optionally) then in thefirst clamp grasping the needle and the needle being released from thesecond clamp.

In yet another aspect, the invention provides a suturing device for usewith a suturing needle. The suturing device comprises a body having aproximal end and a distal end, with a clamp extendable distally of thebody. Biasing means is coupled to the clamp to urge the clamps closedsufficiently to grasp the needle therein for suturing with the needle.An articulatable handle is disposed near the proximal end of the body,and a linkage couples the handle to the clamp so that manualarticulation of the handle opens the clamp to release the needle. Suchsuturing devices may optionally have only a single needle-graspingclamp.

In yet another aspect, the invention provides a suturing device for usewith a suturing needle. The suturing device comprises a rigid bodyhaving a proximal end and a distal end, and a clamp extendable distallyof the body. An articulatable handle near the proximal end of the bodyis configured for manipulation by fingers of a hand while the handengages the body near the proximal end. A linkage coupling the handle tothe clamp so that manual articulation of the handle by the fingerseffects opening and closing of the clamp to grasp and release theneedle. Only a single clamp may be provided, or a plurality of clamps,with the device ideally enhancing control over movement of the needle bythe hand by inhibiting movement of the needle relative to the handduring opening and closing of the clamp.

In yet another aspect, the invention provides a method for securingsuture using a needle driver. The method comprises placing a suturethrough a tissue by grasping a proximal end of a needle with the needledriver and inserting the needle into the tissue at a first insertionpoint. The needle is inserted with the needle driver so that a distalend of the needle protrudes from the tissue at a first exit point. Thedistal end of the needle is grasped by the needle driver and pulleddistally from the tissue, with the suture being coupled to the needle. Afirst suture loop is formed in the tissue by, after the suture has beenplaced through the tissue, again supporting the proximal end of theneedle with the needle driver, inserting the needle into the tissue at asecond insertion point and removing the needle from a second exit pointin a manner similar to that used to first place the suture through thetissue. A second loop is formed in a similar manner, resulting in athird insertion point and a third exit point, and a third loop is alsoformed. The third loop extends across at least one (and preferably both)of the first and second loops between a third exit point and the fourthinsertion point so as to define crossed loops in the suture. The needleis pulled from the fourth exit point sufficiently that the crossed loopssecure the suture to the tissue. Advantageously, this knot may be formedwithout releasing the needle driver from the hand of the surgeon. Theneedle grasping and driving devices described herein are particularlyadvantageous for use in this method.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a suturingdevice with one of the clamps of the suturing device grasping a suturingneedle.

FIG. 2 is a perspective view of a proximal portion of the suturingdevice of FIG. 1, with a cover removed from a proximal housing of thesuturing device to show a portion of a linkage coupling a handle of thesuturing device to the clamps of the suturing device.

FIG. 3 is an exploded perspective view of components of the linkageshown in FIG. 2.

FIG. 4 is an exploded view of a distal portion of the suturing device ofFIG. 1, showing components of a clamp along with a reciprocatable shaftand elements of the linkage that effect movement of the reciprocatableshaft and actuation of the clamp.

FIGS. 5-9 are perspective views showing use of the device of FIG. 1 forsuturing tissues.

FIG. 10 is a perspective view of an alternative suturing device havingfirst and second clamps which both reciprocate and rotate away from asuturing needle after releasing of the needle from the clamp.

FIG. 11 is an exploded view of the suturing device of FIG. 10 showingsome of the components of its drive linkage.

FIGS. 12-14 are partially exploded perspective views showing a portionof an actuation cycle of the suturing device of FIG. 10, and showing howthe clamps both reciprocate and rotate away from the suturing needle.

FIGS. 15-17 are perspective views of components of the suturing deviceof FIG. 10, showing how rotation of the reciprocatable shaft iseffected.

FIG. 18 is a perspective view of another an alternative suturing devicewhich holds a suture needle so that an axis of the needle extends alongan actuation plane of a handle of the device.

FIG. 19 is a perspective view of a suturing system including thesuturing device and needle of FIG. 18, with a cover removed so as toshow components of a linkage coupling the actuatable handles of thedevice to clamps for holding the needle.

FIGS. 20 and 21 are detailed views illustrating reciprocatable shaftsand drive linkages configured to effect movement and actuation of theclamps in the suturing device of FIG. 18.

FIG. 22 is a perspective view of yet another alternative suturing deviceand system having a drive system including a rack and cams.

FIG. 23 is a perspective view of the suturing device of FIG. 22 with acover removed so as to show components of the drive system of thedevice.

FIGS. 24A and 24B illustrate an exemplary suturing device in which theclamps are releasably coupled to the body of the device, allowing theclamps to be disposable to avoid cross contamination between differingpatients without having to sterilize the clamp structures.

FIGS. 25A and 25B are a side view and top cross-sectional view,respectively, of another embodiment of a suturing device having a drivelinkage with an alternatable drive element for moving first one clampand then the other, and also having an alternatable latch for inhibitingmovement of the clamp that is not being driven.

FIG. 26 is an exploded view schematically showing some of the componentsof the drive linkage of the suturing device of FIGS. 25A and 25B.

FIGS. 26A-26M are cross-sectional views schematically illustratingactuation of the linkage of the suturing device of FIGS. 25A and 25B.

FIGS. 27A-27C are perspective views of a distal portion of analternative suturing mechanism in which axially offset clampsalternately grasp proximal and distal portions of a ski-jump suturingneedle.

FIG. 28 is a perspective view of an alternative suturing device having asingle needle-grasping clamp.

FIG. 29 is a side view schematically illustrating a suturing devicesimilar to that of FIG. 25A in which an extension of the body betweenthe clamps and proximal housing has been manually bent for a particularpatient, in which the clamps are actuatable through the bent extension,and which is being grasped by a hand of a surgeon.

FIGS. 30A-30D are perspective views schematically illustrating steps intying a knot, where the knot can optionally be tied by manipulating thetwo-clamp suture devices described herein without the surgeon releasingthe suturing device from his or her hand.

FIGS. 31A and 31B schematically illustrate a suture knot tied accordingto the method of FIGS. 30A-30D.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is generally directed to improved medical suturingdevices, systems, and methods. Exemplary embodiments of the inventionprovide improved suturing devices and methods for suturing tissues thatcan significantly increase the speed and ease of suturing, particularlywhen suturing of long incisions or where large numbers of stitches areto be deployed.

The invention should find a wide variety of applications for stitchinganatomical tissues in both humans and animals. Along with endoscopicoperations (for example, in laparoscopy) these structures and methodsmay find use in other areas of surgery where tissues are to be stitched,providing particular advantages for stitching of large incisions byincreasing the ease and speed with which each individual stitch may beplaced, as well as facilitating and expediting the formation of knots inthe suture. The suturing devices and associated methods described hereinmay, for example, be used suture a wide variety of strata of anatomicaltissues, including (but not limited to) subcutaneous layers, fascia, theouter skin, various organs (including the uterus), and the like. Whileexemplary embodiments are set forth below, these suturing devices andmethods may be applicable to a wide variety of suturing operations,including open surgery, large and small cavity procedures, endoscopicprocedures, microsurgeries (including for suturing of veins, arteries,and the like), and many specialized surgeries. Embodiments of thesedevices and methods may be particularly useful for surgeries involvinglong incisions, including plastic surgeries. A wide variety of bloodvessels, including both veins and arteries, may also be stitched usingthe techniques described herein, for formation of anastomoses and thelike. Along with increasing the speed and/or ease of forming surgicalsuture stitches, embodiments of the invention will often maintain thecontrol a doctor has over the placement of the sutures by maintaining afixed relationship between the movements of the doctor's hand and theinsertion and withdrawal of the suturing needle. Hence, among theprocedures which may benefit from the invention are subcuticularperitoneum, fascia closure, and skin closure.

While embodiments of the invention may include (or be used within) apowered or automated system, optionally making use of electromechanicalpower, hydraulic power, or the like (for example, with some embodimentsbeing included within a robotic system), other embodiments may beconfigured for manual manipulation by one or more hands of a surgeon,often without having to resort to complex subsystems or external power.

Many embodiments of the devices described herein will be sterilizable soas to allow repeated use. Sterilization may be effected using autoclavetechniques, chemical sterilization, irradiation, or the like, with mostor all of the structures of the suturing device being formed ofmaterials suitable for repeated sterilization (such as stainless steel,other metals and alloys, and the like). In general, the suturing devicemay comprise one or more plastics and/or metals common to surgicaldevices. Although specialized or proprietary suturing needles may beemployed in some embodiments (for example, needles having flat grippingsurfaces so as to maintain an alignment between the needle and anassociated clamp), many embodiments of the suturing device will besuitable for use with standard off-the-shelf suture needles such asthose packaged with any of a wide variety of permanent or resorbablesuture materials in a hermetically sealed package. In fact, theinvention may find some of its most immediate applications forfacilitating surgical procedures performed manually in Third Worldcountries, allowing physicians to treat a larger number of patients withgreater ease than can be done using standard suturing techniques, butwithout the cost or complexity of recently-proposed automated suturingsystems.

Referring now to FIG. 1, an exemplary suturing system 100 generallyincludes a suturing device 102 and a needle 1. Needle 1 generally has aproximal end 104 and a distal end 106, with at least the distal endbeing sharpened to facilitate insertion of the needle distally into andthrough tissues. Surgical needles are often formed with a curving shapebetween the proximal and distal ends, and are often packaged with asuture extending from proximal end 104, with the needle sometimes beingreferred to as an acus.

Suturing device 102 generally has a body 112 having a proximal end 108and a distal end 110. A pair of clamps 3 are disposed near the distalend 110, while first and second handles 6, 8 are disposed near proximalend 108. Body 112 may include a proximal housing 7 and a distalextension 4. The distal extension may have a pair of channels, with eachchannel reciprocatably receiving a shaft 2 supporting an associatedclamp 3.

In this embodiment, clamps 3 are mirror-symmetric, although they mayalternatively have differing shapes. Clamps 3 are generally offset so asto grip axially offset portions of needle 1, with one of the clampsgripping a more proximal portion of the needle and the other clampgripping a more distal portion of the needle. When handles 6, 8 are in aclose-handed configuration as illustrated in FIG. 1, only one of clamps3 will typically grip needle 1, the other clamp being retractedproximally away from the needle. Handles 6, 8 have openings forreceiving fingers of the surgeon's hand, and the surgeon will typicallyactuate the handles by opening them from the closed-handed configurationshown to an open-handed configuration 114. Starting with handles 6, 8 inthe closed (as shown in FIG. 1), when the handle is moved to open-handedconfiguration 114 and is then returned to the closed-handedconfiguration, the handle may be described as having completed anactuation cycle.

With each actuation cycle of handles 6, 8, the clamp 3 supporting needle1 is alternated so that a needle initially supported by grasping theneedle in first clamp along a proximal portion of the needle will, whenhandles 6,8 are in open-handed configuration 114, instead be supportedby the second clamp along a more distal portion of the needle. Ashandles 6,8 move back to the closed-handed configuration to complete thecycle, the clamps again alternate, so that closing of the handle resultsin extension of the proximal clamp, gripping of needle 1 with thatproximal clamp, release of the needle from the distal clamp, andretraction of the distal clamp. The position of needle 1 relative tobody 112 may remain substantially fixed throughout the handle actuationcycle, although the shafts may move axially slightly as the needle goesfrom being held by one clamp, to both clamps, and then to the otherclamp, with this movement of the needle being less than a length of theneedle.

Referring now to FIGS. 1 and 2, handles 6, 8 are pivotally attached tohousing 7 of body 112. Housing 7 generally includes at least one lid 9(the top lid shown removed in FIG. 2), with the proximal housingpreferably including opposed first and second lids 9 on opposed majorsurfaces of the body. Lids 9 and the other structures of housing 7generally enclose a drive linkage 116 coupling handles 6, 8 to clamps 3.In the embodiment of FIGS. 1-9, drive linkage 116 generally includes adrive wheel 11 and two driven wheels 10 and 12. The driven wheels 10 and12 are mirror-symmetric and joined by tie rods 14 and 21 to clamps 3.

Referring now to FIGS. 1-3, driven wheel 10 has a thrust surface 24,while driven wheel 12 has a stop surface 23 and an incline 22. Thedriving wheel is supported so as to rotate about an axle 20, the drivingwheel also having a lug 13. The driving wheel 11 is coupled to handles6, 8 by ties 18 and 19, so that actuation of the handles relative to thebody 7 induces rotation of driving wheel 11 about the axle. The drivenwheels 10, 12 rotate coaxially with driven wheel 11.

Lug 13 generally comprises an alternatable configuration drivingelement. Lug 13 either drivingly couples driving wheel 11 with drivenwheel 10, or with driven wheel 12, depending on the configuration of lug13 at the time. More specifically, when lug 13 is disposed above a guide15 as shown in FIG. 2, the lug drivingly couples the driving wheel 11with the upper driven wheel 10. When lug 13 is disposed below guide 15,the lug drivingly engages driven wheel 12, and is disengaged from drivenwheel 10. A reset or release input button 16 interacts with guide 15 anda spring-loaded positioning arm 17 so as to allow both clamps 3 torelease needle 1.

As can be understood with reference to FIGS. 1-4, each clamp 3 isconnected by an associated shaft 2 to the remaining components of drivelinkage 116. Shafts 2 each include a lengthwise slot 118 (see FIG. 4),which allows the shaft to move within the channels of body extension 4.Guiding pins 32 ride in slots 118, and the guiding pins 32 are alsofixed in extensions 4 within openings 5.

Moving wedges 31 within shafts 2 also have lengthwise slots 118 forreceiving guiding pins 32. The wedge surfaces of moving wedges 32 engagecorresponding surfaces of working jaws 25, with the working jaws formingthe open and closable structure of clamps 3. More specifically, distalmovement of moving wedge 31 against a corresponding surface of workingjaws 25 closes clamps 3, the working jaws being attached to a distalclevis of shaft 2 by axle 27. A spring ring 30 biases working jaws 25 toan open configuration, allowing them to move around and capture needle 1before the working jaws are forced shut by the moving wedges.

Working jaws 25 may have a variety of surfaces for holding needle 1, theclamps preferably holding the needle so that movement of the needlerelative to suturing device 100 is inhibited during stitching. Thesurfaces of working jaws 25 may be hardened by deposition of diamond ora diamond-like carbon, or inserts 26 of a material harder than that ofworking jaws 25 may be provided. Optionally, working jaws 25 may havehard-surfaced inserts comprising tungsten and/or cobalt, with theinserts optionally being fabricated using powder sintering or the like.

A return spring 28 extends between pin 28 in working jaws 25 and theguiding pin 32, with the return spring partially fixed within a lumen ofmoving wedge 31. A spring 34 in the proximal portion of moving wedge 31is held by a plug 37, with the distal end of spring 34 interacting withshaft 2 via thrust ring 33. Spring 34 can bring the moving wedge 31 intoa position suitable for releasing the working jaws. A compensationspring 36 pressed against plug 37 writes on a rod 35 of a pusher 42 soas to maintain a desired axial force. Pusher 42 has an insert 40, whichis connected with the pusher 42 by pin 39 and lug 38. The lug rotatesabout axle 41.

When handles 6 and 8 are moved apart to an open-handed configuration114, a retracted clamp 3 and its associated shaft 2 moves from within achannel of body extension 4. While retracted, the moving wedge 31 isbiased by spring 34 away from working jaws 25, so that spring ring 30 isfree to open the clamp to allow it to extend around needle 1. Extensionof compensating spring 34 may be at its greatest point while theassociated clamp 3 is retracted, and insert 40 extends from pusher 42with lug 38 in the insert.

As handles 6 and 8 are brought together, driving wheel 11 is turned byconnector ties 18, 19. Lug 38 interacts with thrust surface 24 of drivenwheel 10 and moves the driven wheel 10 in rotation. The motion of drivenwheel 10 is transferred by tie rod 14 so as to move insert 40 axiallyalong body extension 4. The insert, in turn, moves the pusher 42 alongbody extension 4, the relative position of the insert 40 and pusher 42being maintained by an inner surface of shaft 2 interacting with plug 30so as to inhibit rotation of the plug about axle 41. Pusher 42 pressesspring 34 and compensation spring 32, and via plug 37 and thrust ring33, moves shaft 2. The movement of shaft 2 overcomes spring 29 andextends the shaft from the channel of body extension 4.

During distal movement of pusher 42, spring 34 and compensating spring36 are sufficiently stiff so as to inhibit elongation, as their springcoefficients are significantly higher than that of return spring 29.However, engagement between an end of slot 118 in shaft 2 and guidingpin 32 eventually inhibits further distal movement of the shaft.

Once shaft 2 has stopped its distal movement (due to engagement oflengthwise slot 118 with guiding pin 32), spring 34 begins to contract,its rigidity being lower than that of compensating spring 26. As aresult, moving wedge 31 begins to extend distally relative to workingjaws 25, the corresponding surfaces of the wedge and working jawssliding against each other so as to move the proximal ends of theworking jaws apart and bringing the distal needle gripping inserts 26 ofworking jaws 25 together so as to grasp needle 1. As spring 34contracts, contraction of compensation spring 36 also begins and theinsert 40 moves. When lug 38 extends into and/or engages window 2 a ofshaft 2, pusher 42 engages a surface of body extension 4 or proximalhousing 7, and axial movement of the pusher stops. Insert 40 continuesmoving, so that lug 38 rotates around axle 41. The lug interacts with anedge of shaft 2 and, overcoming compensation spring 36, starts to drawshaft 2 and its contents into body extension 4.

The clamping force on needle 1 by clamps 3 may be determined by thespring characteristics of compensating spring 36 so as to remain withina desired range. Advantageously, the clamping force imposed by suturingdevice 100 on needle 1 may correspond to forces applied by standardneedle holders. Thrust surface 23 of driven wheel 12 approaches a toothof spring-loaded fixing arm 17, and overcoming the spring, the thrustsurface passes under the tooth, releasing the tooth so that the toothand thrust surface are positioned for neutral engagement.

After the thrust surface 23 of the driven wheel 12 passes beyond thetooth of spring loaded fixing arm 17, engagement of the thrust surfaceand tooth inhibit the return of the driving linkage 116 to its priorconfiguration, thereby inhibiting the release of needle 1 from theclosed working jaws 25 so that the needle is not dropped.

As handles 6, 8 continue to move toward the open-handed configuration ofthe handle actuation cycle, movement of driven wheel 12 is inhibited byspring-loaded fixing arm 17. Driving wheel 11 nonetheless turns, and isreset. More specifically, incline 22 of driven wheel 12 moves lug 13from a configuration above guide 15 to a configuration in which the lugis disposed under the guide. Hence, when handles 6, 8 continue to move,here towards a closed-handed configuration, the lug 13 will interactwith thrust surface 24 of the driven wheel 10. The description aboveregarding driven wheel 12 is thus repeated but with driven wheel 10instead. When moving under the spring-loaded fixing arm 17, the thrustsurface 23 of driven wheel 12 lifts the spring-loaded fixing arm 17 andreleases driven wheel 10.

By action of spring 34, moving wedge 31 is retracted proximally frombetween the proximal ends of working jaws 25, so that the proximal endsof the working jaws are brought together by spring-loaded ring 30.Distal ends of working jaws 25 thereby move apart and the needle isreleased.

Each repeated opening and closing actuating cycle of handles 6, 8alternates the needle between being held by one, and then the other ofclamps 3, and often back to the first clamp. In other embodiments, eachhandle actuation cycle effects transfer of the needle from one clamp tothe other, with the needle returning to be held solely by the firstclamp only with a second handle actuation cycle. Regardless, during eachcycle each retracted clamp is preferably extended around an associatedportion of needle 1 and is closed before the previously extended clampopens, so that the needle is held continuously by at least one of clamps3 throughout the handle actuation cycle.

If it is desired to release needle 1 from suturing device 112 at anytime during, before, or after a handle actuation cycle, release can beeffected by pressing on release input button 16. Pressing on button 16causes spring-loaded fixing arm 17 to lift away from driven wheels 10and 12, thereby resetting the clamps in their proximal openedconfiguration.

Referring now to FIGS. 5-9, the use of suturing device 102 for suturingan incision I in tissue T can be understood. Initially, handles 6, 8(see FIG. 1) are in a closed-handed configuration and the handles aregrasped by a hand of a surgeon. Needle 1 is supported by a first clamp 3a, with the first clamp grasping a proximal portion of the needleadjacent a suture S. The second clamp 3 b is retracted proximally awayfrom needle I, so that a distal portion of the needle is free andexposed, as illustrated in FIG. 5.

As can be understood with reference to FIG. 6, the surgeon manuallymoves suturing device 102 by manipulating handles 6, 8 so as to insert adistal portion of suturing needle 1 through tissue T. Advantageously,body 112 and linkage 116 (see FIG. 2) of suturing device 102 inhibitsrelative movement of needle 1 relative to the body and handles 6, 8 ofthe suturing device while the handles are closed. This allows thesurgeon to precisely control movement of the needle 1 as it is insertedthrough the tissue, in a manner analogous to manual manipulation of theneedle using a standard needle grasper or forceps. As can be understoodwith reference to FIGS. 6 and 7, once the distal portion of needle 1extends sufficiently through the tissue, handles 6, 8 can be cycledthrough at least a portion of their actuation cycle. Through the linkage116, second clamp 3 b is extended distally from body 112 of suturingdevice 102, grasping the distal portion of needle 1. The first clamp 3 athen releases needle 1 and is withdrawn proximally from around theneedle, as illustrated in FIG. 8.

As can be understood with reference to FIGS. 8 and 9, once needle 1 isheld by second clamp 3 b, the surgeon can again manipulate the needle bymoving handles 6, 8. In some embodiments, the surgeon can grasp thehandles in an open-handed configuration while pulling the needle freefrom the tissue, while in other embodiments the needle will be pulledafter the handle has returned to the closed-handed configuration.Regardless, the surgeon uses the handles, body, and clamp 3 b to pullthe proximal portion of needle 1 through tissue T, thereby leavingsuture S inserted across incision I.

Prior to initiating a second stitch, the surgeon can cycle handles 6, 8by closing the handles with his/her hand, or by opening and closing thehandles through a full actuation cycle. This results in grasping ofneedle 1 by first clamp 3 a and release of the needle by second clamp 3b, exposing the distal portion of the needle and displacing the secondclamp from the needle so that the needle is ready to again insertthrough tissue T, as can be understood with reference to FIG. 5. Theprocess can then be repeated without ever having to completely releaseneedle 1, and by simply actuation of handles 6, 8 after insertion of thedistal portion of the needle through the tissue and again after eachpulling of the needle free. The process is repeated to form as manystitches as is desired. Analogous insertion of the distal portion of theneedle through loops of suture, actuation of the handle, and pulling theneedle free can be used to quickly and easily form knots.

As can be understood from the illustrations in FIGS. 5-9, and as may beindicated by the detailed description above of the articulation of thedrive linkage, shafts 2 extending distally from body 112 to clamps 3 a,3 b may move slightly during the handle actuation cycle, for example,with the shaft supporting the clamp initially holding needle 1retracting slightly into body 112 as the other shaft extends.Nonetheless, each clamp holds the needle at a fixed location while thesurgeon holds the handles 6, 8 in the closed configuration and insertsor withdraws the needle into or from the tissue.

Referring now to FIGS. 10-22, a wide variety of alternative linkagemechanisms, clamp structures, housing, handles, and the like may beemployed. Referring first to FIG. 10, an alternative suturing device 130may include clamps 43, 44 which both retract proximally and rotate awayfrom needle when not used to hold the needle. Referring now to FIGS.10-17, and avoiding describing structures which are substantiallysimilar to those described above, clamps 43 and 44 have bent-shapedinserts 54 made of a hard alloy (see FIG. 15). Proximal ends of clamps43 and 44 may have conical surfaces 55 which are located, sized, andconfigured so as to interact with a distal port of shaft 47, and morespecifically, so that proximally withdrawing the working jaws of clamps43, 44 into sleeve 47 closes the working jaws of these clamps.

Shaft 47 has a lengthwise slot 52 for receiving a guiding pin, while aproximal extension of the working jaws of clamps 43, 44 has a spirallengthwise slot 51 receiving guiding pin 48. Shafts 47 are connectedwith pushers 53, and ride in distal body extension 45, with the distalbody extension again having openings for receiving the guiding pins.

In alternative suturing device 120, as the guiding pins 45 ride withinspiral slot 51 due to axial motion of clamps 43, 44, the clamp rotatesaway from a needle 1 about the axis of shaft 47 when the clamp retractsproximally.

The rotation of clamps 43, 44 with axial movement of shafts 47 aseffected by actuation of handles 6, 8 can be understood with referenceto FIGS. 12-13. As can be seen in FIG. 12, a first rotatable clamp 43holds a proximal portion of needle 1 while handles 6, 8 are in aclosed-handed configuration, while second rotatable clamp 44 is bothwithdrawn proximally and rotated clear of the needle. As the handlesbegin to open, as illustrated in FIG. 13, distal movement of shaft 47 ofsecond rotatable clamp 44 imparts a twisting motion to the clamp due tothe interaction between the guiding pin 48 and the helical slot 51 (seeFIG. 11). The second rotatable clamp 44 can rotate into position andextend around needle 1, with the second clamp 44 grasping needle 1 andfirst clamp 43 withdrawn proximally and rotated free from the needlewhen the handles are in their fully opened configuration. Once again, afull actuation cycle from a closed configuration to an openconfiguration and back to a closed configuration may result in theneedle alternating from being grasped by the first clamp along aproximal portion of the needle, then being grasped by the second clampalong a more distal portion of the needle (with the handles in the openconfiguration), and with the needle again being grasped solely by thefirst clamp when the handles are returned to the closed configuration.The structure and rotation of rotatable clamps 43, 44, along with theassociated interaction between shaft 47 and guiding pin 48 are alsoillustrated in FIGS. 15-17.

Referring now to FIGS. 18-21, a still further alternative suturingdevice 140 has first and second clamps 142, 144 formed by working jaws56, 57 connected at an axle 58. The shafts supporting clamps 142, 144here comprise flattened structures 60 located within channels of bodyextension 61. Shafts 60 interact with rods 67 of pusher 63. This linkagecouples handles 62 to clamps 142, 144 using a moveable rod 65 and animmovable fixing arm 66, along with a flat spring 64. Rods 67 of pushers63 have inclines 68 which function to open and close the clamps, as canbe understood with reference to FIGS. 20 and 21.

Note that in embodiment 140, needle 1 generally extends along a plane ofactuation of handle 62. In contrast, in suturing device 102, illustratedin FIG. 1, needle 1 generally extends across the handle actuation plane.Ergonomically, there may be advantages in orienting the needle so thatit traverses the handle actuation plane as shown in FIG. 1. Such aconfiguration may conveniently be used by either a right hand or a lefthand of the surgeon, although embodiments configured for use by only oneor the other may also be provided.

Referring now to FIGS. 22 and 23, yet another alternative suturingdevice 160 has an external appearance somewhat similar to suturingdevice 140 of FIGS. 18 and 19, but makes use of a significantlydifferent linkage mechanism for coupling handle 72 to clamps 69, 70. Theclamps again extend from associated channels in body 71, but the linkagehere makes use of a rack 77 actuated by a rod 84.

First clamp 69 has elongate levers 73 and 74, while second clamp 70 haslevers 75 and 76. Tie rods 83 and 85 axially actuate rack 77 via rod 84,resulting in rotation of cams 78, 79, and large cams 81, 82. The largecams axially extend associated levers 74 and 75 so as to axially extendtheir associated clamps, while a spring 80 proximally withdraws theclamps when allowed by their cams. The small cams open and close theclamps via levers 73 and 76, with the levers generally acting asfollowers along the cam surfaces.

Referring now to FIGS. 24A and 24B, an alternative suturing devicesystem 202 may include many functional components which are similar tothose described above, but can generally be separated into a reusabledrive unit 204 and a disposable clamp unit 206. A releasable coupler 208releasably couples clamp unit 206 to the drive unit 204. The exemplarycoupler includes an interface that provides rigid coupling betweenextensions 210 of the clamp unit 206 and proximal housing 212 of driveunit 204, and also provides moving engagement surfaces between theshafts of the clamp unit and axially moving elements of the drivelinkage. While the exemplary releasable coupler 208 includes axialpositioning surfaces (in the form of a pin of drive unit 204 andcorresponding aperture of clamp unit 206) and a releasable latch toavoid inadvertent decoupling, a wide variety of alternative releasablecouplers might also be employed. The exemplary clamp unit includes twoclamps. In some embodiments, each clamp may be individually attached toa drive unit 204. Regardless, allowing the clamps to be detached fromthe drive unit can avoid any need for making the clamps sterilizable,decreasing overall costs of the suturing system and helping to ensurethat cross-contamination between patients is inhibited. A plurality ofclamp units 206 will often be used with each drive unit 204, with eachclamp being used for a single patient and then being disposed of

A still further exemplary suturing device embodiment 220 can be seen inside and cross-sectional top views in FIGS. 25A and 25B. An elongateextension 222 coupling proximal housing 224 to clamps 226 may facilitateuse of suturing device 220 in endoscopic surgery or the like. In thisembodiment, actuation of drive linkage 228 is generally effected bymovement of a single articulatable handle 230 relative to a graspingbase 232 that is affixed to proximal housing 224. By allowing thesurgeon to grasp a structure that remains rigidly affixed relative tothe suturing device body with one portion of the hand, and articulatehandle 230 with the fingers of that hand, the overall position ofsuturing device 220 (and clamps 226, along with any needle supportedtherein) can be accurately maintained. As with the other embodimentsdescribed herein, a release 233 will often be provided that, whenactuated, releases a needle from both clamps and sets the two clamps ina needle-receiving configuration.

The components and use of drive linkage 228 of suturing device 220 canbe understood with reference to FIG. 26 and FIGS. 26A-26M. As generallydescribed above, drive linkage 228 includes an alternatable driveelement 230 for alternating the driving of first one and then the otherof the two clamps. Additionally, drive mechanism 228 includes analternating latch or anchor 232 for inhibiting axial movement of theclamp that is not currently being driven. Drive linkage 228 furthermakes use of a channel casing 234 in which a movable tubular shaft 236slides along an axis 238. First and second pushers 240, 242 and a conewith a rod 244 are disposed along axis 238, while a striker 246 and astop pin with a spring 248 are disposed off of axis 238.

Reviewing the sequence of actuation of these components schematically,FIGS. 26A shows the components of drive linkage 228 at a beginningconfiguration (such as after actuation of the release), with both clamps226 in a configuration that is open and ready to receive a needle. InFIG. 26B, alternatable drive element 230 drives a first shaft 236distally along its axis till the shaft engages pin 248. Needle 250 isdisposed within the clamp, with the alternatable drive element 230continuing to move axially with movement of the handle.

In FIG. 26C, continuing movement of drive element 230 has produced axialmovement of pin 248 so as to compress its spring, so that the pin stopsmoving axially. As a result, continuing movement of drive element 230does not produce additional movement of shaft 236, but instead causesthe cone with its rod 244 to move within the shaft 236 till it reachesits distal position, as shown in FIG. 26D.

Additional movement by drive element 230 results in axial movement ofpushers 240, 242, causing the striker 246 to move into alignment with awindow in the shaft 236, and thus allowing the striker to engage andreposition latch 232. As the reconfigured latch 232 inhibits proximalmovement of shaft 236, the handle may be returned (often to its extendedposition, as can be understood with reference to FIG. 26F) withoutmovement of shaft 236.

Once the handle returns to its starting or extended position, needle 250may be inserted into and through the tissue. Returning of the handlealso reconfigures alternatable drive element 230 to engage the other,previously non-driven clamp actuation components, with the other shaft236 again moving distally along its axis due to movement of the handleto engage and compress pin 248 (as seen in FIGS. 26H and 261), inducingaxial movement of the cone and rod 244 and allowing the associatedstriker to again reconfigure the alternatable latch 232 (see FIGS. 26Jand 26K). Reconfiguring the latch allows the extended, non-driven clamp226 to retract proximally to the configuration shown in FIG. 26L underthe influence of its proximal return spring, this retraction optionallyoccurring quite quickly. The handle may now again be released, with thereconfigurable drive element 230 again being reset to alternate thedriven and latched clamps, as shown in FIG. 26M.

Structures and methods which inhibit gradual displacement of needle 250relative to suturing device 220 during repeated cycling of drive linkage228 can be understood with reference to FIGS. 261 and 26K. As each clamp226 is extended to grasp needle 250, the clamp advances distallyslightly beyond the eventual location at which the clamp will hold theneedle for suturing. This stresses and/or displaces the needle slightly,and the clamp then grasps the needle at the extended location. Theextended location will typically be less than 20 diameters of the needlepast the other clamp, typically being a few needle diameters distal ofthe other clamp (smaller needles generally employing smallerstress-inducing distances). The grasping clamp that is to retain needle250 is retracted slightly to the grasping location and the other clampis opened, so that needle 250 is positioned for the next cycle, i.e., sothat the other clamp will again stress the needle before it is grasped.This slight alternating overshoot during grasping of the needle helpsmaintain the needle near the proximal end of the grasping jaws duringcycling. The needle may also be manually pre-angled by the surgeon,either proximally or distally, to facilitate proximal or distalsuturing. For example, the distal tip of the needle may extend or angledistally of the grasping clamps, rather than the needle being disposedperpendicular relative to the axes of the shafts. Cycling of drivelinkage 228 will largely reproduce and maintain the grasping angle asthe clamps alternatingly grasp the needle, with some gradual trendtoward a perpendicular needle induced by the alternating overshootduring large numbers of actuator linkage cycles (for example, withmovement of the distal portion of the needle proximally along the jawsby a few needle diameters or less with each cycle). Hard metal insertswith small protrusions or teeth along the grasping jaw surface may alsobe beneficial to limit inadvertent movement of the needle relative tothe jaws.

Referring now to FIGS. 27A-27C, a wide variety of alternative suturingdevice clamping arrangements may also be employed. An axially concentricsuturing device 260 is particularly well suited for use with a ski jumpneedle 262. Such needles may comprise a proximal straight section and adistal curving section, and may be commercially available from a numberof suppliers with suture affixed thereto (not shown). A proximal clamp264 and distal clamp 266 have clamping jaw members which separate androtate away from needle 262 to allow the needle to be inserted intotissue (in the configuration of FIG. 27A). The drive system may transferthe needle between the two clamps (FIG. 27B), and allow the needle to bepulled distally free of the tissue (in the configuration of FIG. 27C),with the clamps opening and closing with the cycling of a handle usingdrive elements that may be similar to, analogous to, or quite differentthan at least some of the drive components described above.

Referring now to FIG. 28, an alternative suturing device 270 may makeuse of many of the drive components described above, but may include asingle clamp 272. Rather than passing a needle back and forth betweentwo clamps, suturing device 270 may be used in a manner analogous tostandard needle drivers, and may be particularly well suited for use inthe endoscopic or other minimally invasive surgeries.

FIG. 29 schematically illustrates a suturing device 280 similar to thatof FIGS. 25A and 25B, with extension 282 between clamps 284 and proximalbody housing 286 here having a bend 288. While such suturing devices mayoptionally be sold in a pre-bent configuration, bend 288 mayalternatively be imposed by a surgeon, with the surgeon manually (oroptionally, with the assistance of one or more tools) bending theextension (or another structure supporting the clamps) to a desiredconfiguration for use in a surgical procedure on a particular patient.Extension 282 may be formed of a material (typically comprising a metalor polymer) which can withstand bend 288 while maintaining structuralintegrity of the suturing device, and the drive components which movewithin bend 288 (such as the axially movable shaft, rod with a cone, orthe like) may be formed of a material (or having a configuration) whichcan accommodate lateral deflection within the bent tubular extensionduring the actuation, such as by forming drive components of a suitablepolymer, making use of at least a portion of the drive components whichare formed as a helical coil, including thin, flexible sheet metalcomponents, or the like. In general, reconfiguring the drive componentsor support structures to employ bent sheet metal parts may also helpreduce manufacturing costs, and the like. Hence, the shaft may (forexample) comprise a sheet metal structure with end tabs having openingsto receive components therein, and/or the like. The positive control orpositioning of clamps 284 which can be available using a grasping basethat's originally affixed to the body housing 286 when suturing device280 is held by a hand H of a surgeon can also be understood withreference to FIG. 29.

Referring now to FIGS. 30A-30D and FIGS. 31A and 31B, methods for tyinga knot 302 can be understood. Knot 302 may be particularly advantageousfor tying with any of the suturing devices described herein, and mayalso be employed with other needle drivers and/or suturing devices.

As seen in FIGS. 30A and 30D, a first tissue portion T1 may be affixedto a second tissue portion T2 using a needle 304 and a suture 306affixed thereto. The needle has a sharpened distal end and suture 306 isaffixed to a proximal end of the needle, with the needle and suturetypically comprising any of the commercially available surgicalstructures. The needle is inserted distally through the tissue portionsas shown in FIG. 30A, for example, on either side of an incision or thelike, with the needle entering the tissue at a first insertion point 308a and exiting the tissue at a first exit point 310 a. A first clamp ofthe suturing device may effect movement of the needle from the proximalend portion during insertion, while a second clamp of the suturingdevice may grasp and pull the distal end portion while the needle ispulled from the tissue, as explained above. The suturing device or otherneedle driver will not be shown for simplicity.

As seen in FIG. 30B, a first loop 312 a is completed by again passingthe needle through the tissue T1, T2, with the needle entering thetissue at a second insertion point 308 b and exiting from a second exitpoint 310 b that are near the first insertion point and first exitpoint, respectively. As seen in FIG. 30C, a second loop 312 b issimilarly formed using an adjacent third insertion point 308 c and thirdexit point 310 c.

Referring now to FIGS. 30D and 31B, a third loop 312 c (with associatedfourth entry point 308 d and fourth exit point 310 d) are formed, withthe external portion of the third loop crossing an exposed portion of atleast one of the first loop 312 a and the second loop 312 b. Third loop312 c preferably crosses both first loop 312 a and second loop 312 b, asshown. Additional loops may be formed before, between, and/or after thefirst, second, and third loops 312 a-312 c, and the suture loops may bepulled tight after each is formed or only after more than one is formed.

After forming of the third loop, the needle and/or suture distal of thethird loop is pulled sufficiently tight to bring the crossing suturesinto firm engagement. The suture tension on the outer third loop pressesagainst the inner first and/or second loop, which is counteracted by thecompression of the encircled tissue within the inner loops. This, withthe friction between suture and the tissue, can effectively anchor thesuture to the tissue and prevent axial movement of the suture when thesuture proximal of knot 302 is pulled proximally, and/or when the suturedistal of the knot is pulled distally.

Advantageously, knot 302 can be tied using motions similar to those usedto form basic stitches, preferably without having to remove a needledriver or grasper such as the suturing devices described herein from thehand of the surgeon, optionally using only one hand of the surgeon(often that holds the suturing device) to completely form the knot.Additionally, deleterious abrasion of the suture (such as that which canoccur when other knots are tied away from the tissue and then moved downthe suture to the tissue) can be reduced or effectively eliminated.

While exemplary embodiments of the invention have been described indetail, by way of example and for clarity of understanding, a variety ofmodifications, changes, and adaptations will be obvious to those ofskill in the art. For example, along with the exemplary drive linkagesdescribed herein, still further drive linkages may be provided,including those making use of cables and pulleys, worm gears, and thelike. Hence, the scope of the present invention is limited solely by theappended claims.

1. A suturing method for suturing a tissue of a patient, the methodcomprising: inserting a distal portion of a suturing needle distallythrough the tissue by moving a body of a suturing device while a firstclamp of the suturing device holds a proximal portion of the needle at afixed location relative to the body of the device; grasping the distalportion of the inserted needle with a second clamp of the suturingdevice; releasing the proximal portion of the needle from the firstclamp; moving the first clamp away from the needle by axially moving thefirst clamp away from the needle and by rotating the first clamp awayfrom the needle; and pulling the proximal portion of the needle throughthe tissue by moving the body while the second clamp holds the needle atthe fixed location.
 2. The suturing method of claim 1, wherein the firstclamp is included in a clamp assembly having a first shaft, the firstclamp holding the proximal portion of the needle offset laterally fromthe first shaft, wherein the first clamp moves away from the needleusing axial movement of the first shaft relative to the body androtation of the first shaft relative to the body, and furthercomprising: advancing the first clamp axially along the shaft toward theneedle and rotating the first clamp about the shaft toward the needle;and grasping the proximal portion of the needle with the first clamp ofthe suturing device while the second clamp restrains the needle near thefixed location.
 3. The suturing method of claim 2, wherein grasping theneedle with the first or second clamp comprises: positioning the needlewith the clamp by axially moving the clamp to contact the needle; andclosing the clamp on the needle.
 4. The suturing method of claim 1,wherein moving the first clamp axially and rotating the first clampoccurs in response to a single actuation of a handle disposed near aproximal end of the body, the body extending from the proximal endtoward the clamps.
 5. The suturing method of claim 2, wherein graspingthe needle with the first or second clamp comprises grasping the needlewith a pair of jaws of the clamp.
 6. The suturing method of claim 5,wherein an insert is attached to at least one of the pair of jaws. 7.The suturing method of claim 5, wherein grasping the needle with eitherthe first or second clamp further comprises closing the clamp so as tograsp the needle with the pair of jaws of the clamp, and wherein closingthe clamp comprises axially moving a wedge surface to engage acorresponding surface of the pair of jaws so as to close the pair ofjaws.
 8. The suturing method of claim 2, wherein releasing the needlefrom the first clamp comprises opening the first clamp, the first clampremaining open as the first clamp moves axially away from the needle. 9.The suturing method of claim 8, wherein closing the clamp compriseswithdrawing a conical surface at a proximal end of each of a pair ofjaws of the clamp into a sheath.
 10. The suturing method of claim 2,wherein axially moving the first or second clamp and rotating the clampabout its shaft comprises moving the clamp in a spiral motion relativeto the body of the device.
 11. A suturing device for use with a suturingneedle, the device comprising: a body having a proximal end and a distalend; a first clamp assembly including a first clamp mounted at a distalend of a first shaft, the first shaft extending distally from the body;a second clamp assembly including a second clamp mounted to a secondshaft, the second shaft extending distally from the body; each clampassembly having a grasping configuration wherein the clamp is extendeddistally along its shaft and the clamp is substantially closed so as tograsp the needle; each clamp assembly having a displaced configurationwherein the clamp is moved proximally along its shaft and the clamp isrotated away from the needle about the shaft; a linkage effectingmovement of the first or second clamp between the grasping configurationand the displaced configuration so that the needle substantially remainsat a fixed location relative to the body when support of the needlealternates between the clamps.
 12. The suturing device of claim 11,further comprising a handle disposed at the proximal end of the body andcoupled to the first and second clamps by the linkage so that actuationof the handle alternates between: the first clamp in the graspingconfiguration and the second clamp in the displaced configuration; andthe second clamp in the grasping configuration and the first clamp inthe displaced configuration.
 13. The suturing device of claim 11,wherein the linkage rotates the clamp and moves the clamp proximallyalong its shaft from the grasping configuration to the displacedconfiguration.
 14. The suturing device of claim 11, wherein the linkagecomprises a guiding pin disposed in a helical slot of the shaft of eachclamp such that moving the shaft proximally or distally of the guidingpin imparts a twisting spiral motion to the clamp.
 15. The suturingdevice of claim 11, further comprises an insert attached to at least oneof the jaws of the first or second clamp so as to grasp the needle whenthe clamp is in the grasping configuration.
 16. The suturing device ofclaim 11, wherein the first or second clamp is closed when the clamp isin the grasping configuration.
 17. The suturing device of claim 11,wherein the first or second clamp is open when the clamp is in thedisplaced configuration.
 18. The suturing device of claim 11, comprisinga spring that opens the jaws of the first or second clamp when the clampis moving between the grasping and displaced configurations.
 19. Thesuturing device of claim 18, further comprising a conical surface at aproximal end of each jaw of either pair of jaws of the each of theclamps such that moving the clamp proximally into the displacedconfiguration retracts the conical surfaces of the pair of jaws into asheath so as to close the jaws.
 20. The suturing device of claim 18,further comprises a wedge surface attached to the sheath of each clamp,wherein the wedge surface is engageable with a corresponding surface onthe proximal end of each of the pair of jaws such that advancing theclamps to the grasping configuration axially moves the wedge surfacewhich engages the wedge surface with the corresponding surface so as toclose the pair of jaws.